Duns Number:315471722
Device Description: TPH Spectra ST Shade Guide Refill is an accessory that allows visual shade selection : sel TPH Spectra ST Shade Guide Refill is an accessory that allows visual shade selection : select the shade closest to the area to be restored.
Catalog Number
642013
Brand Name
TPH Spectra ST
Version/Model Number
642013
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
0c47fbff-0021-4600-bc55-27c9d9f1b6a1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 14, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |